News

The Mutual Recognition Agreement (MRA) allows drug inspectors from the U.S. Food and Drug Administration (FDA) and the European Union (EU) to utilize each other’s inspection data while conducting inspections in one another’s countries. This agreement creates greater efficiency between the two agencies by avoiding redundant inspections and enabling the agencies to better allocate resources towards inspections of drug manufacturing facilities in other countries.

The Agreement applies to EU countries that FDA has recognized as having a capable inspectorate. As of July 11 2019, all 28 countries across the EU have been approved. FDA and EU inspectorates will still perform some inspections in each other’s countries; however, the goal of the agreement is to cut down on routine inspections. The agreement also waives batch testing, allowing EU pharmaceutical companies to forego carrying out quality controls for products manufactured in and imported from the U.S. if those controls were already done by the U.S. company.

Background

In 2012, U.S. Congress passed the Food and Drug Administration Safety and Innovation Act, which allowed FDA to enter agreements with foreign regulatory agencies to allow them to rely upon their information from drug inspections, provided FDA recognizes the country’s inspectorates as capable. Since 2014, FDA and EU have been collaborating to assess how they each inspect drug facilities. In 2017, FDA recognized the first group of countries within the EU as capable for the agreement.

What products does the MRA cover?

The Agreement covers most human drugs, biologics, and veterinary drugs, but there are exclusions. Veterinary products are not currently included, but will be considered by December 15, 2019. Current good manufacturing practices (CGMPs) of facilities manufacturing vaccines and plasma derived products are not included, but will be considered by July 15, 2022. The following products are not included and are not being considered:

Human blood

Human plasma

Human tissues and organs

Veterinary immunologicals

Enforcement Actions

The FDA and the EU will still conduct drug facility inspections in one another’s countries, so it remains important to be prepared for that possibility. However, it is expected to be uncommon, as FDA and EU inspectorates will now utilize each other’s information for drug facility inspections. The FDA and EU also reserve the right to enact enforcement against a facility regardless of what the other agency does. For example, if the EU takes an enforcement action against a facility that does not necessarily mean FDA will do the same. It should be expected that the effect of different enforcement actions will be similar, however.

Registrar Corp is a private company that assists businesses in complying with FDA. We can help your drug company meet FDA requirements. For more information, contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.